Loteprednol Etabonate
Loteprednol Etabonate Ophthalmic Suspension, 0.5%
Approved
Approval ID
66977c58-1e0c-4add-8ff1-c90050dbcd10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loteprednol Etabonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50383-265
Application NumberANDA207609
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loteprednol Etabonate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 15, 2022
FDA Product Classification
INGREDIENTS (9)
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 mL
Code: YEH1EZ96K6
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT